Skip to main content
MedPathMedPath Home
Clinical Trials/NCT01410149
NCT01410149
Completed
Not Applicable

The Influence of Mode and Patient-ventilator Interaction on Sleep Quality in the ICU

Lawson Health Research Institute1 site in 1 country13 target enrollmentApril 2007
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsRespiratory Failure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Failure
Sponsor
Lawson Health Research Institute
Enrollment
13
Locations
1
Primary Endpoint
Sleep quality
Status
Completed
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

Patients requiring mechanical ventilation in the ICU will undergo three consecutive nights of polysomnography to record sleep patterns while receiving three modes of mechanical ventilation; Proportional assist ventilation (PAV), Pressure support ventilation (PSV), Assist control ventilation (ACV), applied in random order. The purpose is to determine the effect of mode of mechanical ventilation on patient-ventilator asynchrony and sleep quality.

Registry
clinicaltrials.gov
Start Date
April 2007
End Date
December 2011
Last Updated
13 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Karen Bosma

Principal Investigator

Lawson Health Research Institute

Eligibility Criteria

Inclusion Criteria

  • •Age 18-75
  • •received mechanical ventilation \>72 hours
  • •glasgow coma scale \>10
  • •acute physiology score \<13
  • •ready for partial ventilatory support: intact respiratory drive, PaO2/FiO2 ratio \>200 on positive end expiratory pressure (PEEP) less than or equal to 5 cmH2O, and PH of 7.35 to 7.45
  • •sedation: analgesia at dose not higher than 0.01 mg/kg/hr morphine equivalent x 48 hours, sedation at dose not higher than 0.01 mg/kg/hr lorazepam equivalent x 72 hours.
  • •anticipate ongoing need for partial ventilatory support for the following 72 hours

Exclusion Criteria

  • •Successful completion of spontaneous breathing trial
  • •Neurological injury, encephalopathy or abnormal EEG
  • •History of central sleep apnea
  • •General anaesthesia within 72 hours from study entry
  • •Requiring haloperidol \>10 mg/24 hours
  • •hemodynamically unstable

Outcomes

Primary Outcomes

Sleep quality

Time Frame: 3 nights

Sleep fragmentation (number of arousals and awakenings/hr sleep), sleep architecture (% time asleep spent in Stage 1, 2, 3/4 and REM sleep)

Secondary Outcomes

  • Patient-ventilator asynchrony(3 nights)

Study Sites (1)

Loading locations...

Similar Trials

Completed
Not Applicable
Influence of Patient/Ventilador Decoupling in Neurocognitive and Psychopathological Sequelae in ICU PatientsCritical Illness
NCT02390024Corporacion Parc Tauli156
Completed
Not Applicable
Biomarkers in Patients Undergoing Mechanical VentilationVentilator Associated Pneumonia
NCT02078999Corporacion Parc Tauli211
Unknown
Not Applicable
Individualised Weaning From Mechanical Ventilation in General ICUVentilatory Failure
NCT03249623Chelsea and Westminster NHS Foundation Trust274
Not yet recruiting
Not Applicable
Study of Sleep Quality in the Intensive Care Unit and Association with Weaning from Invasive Ventilation in Patients with Chronic Obstructive Bronchopneumopathy.COPDCOPD ExacerbationVentilated PatientsVentilator-Associated Pneumonia (VAP)Ventilator WeaningWeaning of Mechanical VentilationSleep QualitySleep Disorders, Circadian RhythmSleep DisordersFailure, RespiratoryICU HospitalizationICU Sedation
NCT06653933University Hospital, Grenoble42
Completed
Not Applicable
Individualized Perioperative Open Lung Ventilatory StrategyModerated-high Risk of Postoperative Pulmonary ComplicationAbdominal Surgery Expected More Than Two Hours
NCT02158923Fundación para la Investigación del Hospital Clínico de Valencia920